What this instrument does
The Therapeutic Goods (Medicines - Foreign Countries) Determination 2026 is a new legislative instrument registered on the Federal Register of Legislation. It came into force on 19 August 2026. The instrument is made under the Therapeutic Goods Act 1989 and is administered by the Department of Health, Disability and Ageing.
The Determination lists which foreign countries are recognised for the purposes of medicines regulation in Australia. It repeals and replaces the older Therapeutic Goods (Foreign Countries) Determination 2016.
What the source does not specify
The source summary does not specify which countries are listed in Schedule 1 of the 2026 Determination, nor does it detail what practical changes have been made compared to the 2016 version.
Key actions
- Businesses that import, distribute, or register medicines relying on foreign country recognition under Australian therapeutic goods law are required to review the full text of the Determination at https://www.legislation.gov.au/F2026L01079 to check whether the countries they rely on are still listed in Schedule 1.
- Any internal compliance documents or supplier agreements that previously referenced the 2016 Determination are required to be updated to reference the 2026 Determination (F2026L01079), which is now the current instrument in force.
- The Department of Health, Disability and Ageing is the contact point for clarification on how this change affects specific products or registrations. The source does not provide a direct contact for enquiries.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.